- New Data from Open-Label Study Presented at Federation of Clinical
Immunology Societies (FOCIS) Annual Meeting -
CARLSBAD, Calif., June 11 /PRNewswire-FirstCall/ -- Orchestra
Therapeutics, Inc. (Bulletin Board: OCHT) announced today positive new data
from its completed Phase II open-label study of NeuroVax(TM), an
investigational T Cell Receptor (TCR) peptide vaccine for the treatment of
relapsing-remitting multiple sclerosis (MS). The new data, presented last
week at the Federation of Clinical Immunology Societies (FOCIS) annual
meeting, showed that monthly vaccinations over one year with NeuroVax(TM)
markedly expanded the capacity of regulatory T cells (Tregs) to recognize
TCRs expressed by potentially pathogenic T cells. New data were also
presented that showed NeuroVax(TM) produced a significant increase in
TCR-specific T cells in patients with MS, including increases in
interleukin-10-secreting T cells (IL-10) and Foxp3+ Tregs.
"These new findings provide evidence to support the network hypothesis,
in which internal cell-cell recognition of antigen receptors can be greatly
expanded in regulatory T cells by activating the system with NeuroVax(TM).
These vaccine induced responses may help control the autoimmune processes
that are thought to be the main cause of the inflammatory phase of MS" said
Arthur A. Vandenbark, M.D., Ph.D., Senior Research Career Scientist at the
VA Medical Center, and Professor of Neurology and Molecular Microbiology
and Immunology at Oregon Health & Science University in Portland, OR., and
lead author on the study. "Increases in both IL-10-secreting T cells and
the Foxp3+ Tregs suggest that NeuroVax(TM) can stimulate native
thymus-derived Foxp3+ Tregs as well as induce peripheral Foxp3+ Tregs from
CD4+CD25- T cells through an IL-10 controlled mechanism."
"These new data suggest that induction of an expanding population of
TCR-reactive, Foxp3+ Tregs by NeuroVax(TM) may be able to exert broad and
potent immunomodulatory effects on pathogenic T cells," said Dr. Joseph
O'Neill, President and CEO of Orchestra Therapeutics, Inc. "The indication
that this vaccine candidate increases both native and induced types of
Foxp3+ Tregs against a broad population of pathogenic T cell families is
also important as it provides further insight into the targeted mechanism
of NeuroVax(TM). Orchestra Therapeutics is investigating how this TCR
peptide vaccine technology, pioneered with NeuroVax(TM), could be leveraged
to develop similar therapeutic vaccines for other autoimmune diseases such
as rheumatoid arthritis (RA) and psoriasis."
In MS, a specific subset of a patient's own white blood cells,
pathogenic T cells, attack myelin, a fatty tissue in the central nervous
system, which surrounds and protects nerve fibers. This pathologic process
creates multiple areas of inflammation that ultimately lead to scarring
(sclerosis) and that interfere with normal transmission of nerve impulses.
This nerve damage, in turn, leads to a variety of chronic and often
debilitating neurological symptoms, ranging from serious movement and
balance problems to vision impairment.
NeuroVax(TM), which is currently being tested in a double-blind,
placebo-controlled 200-patient Phase II study, may represent a significant
advance in the treatment of MS, which affects more than 2.5 million people
worldwide, including more than 400,000 in the United States. NeuroVax(TM)
has been shown to stimulate strong, disease-specific cell-mediated immunity
in nearly all treated patients. NeuroVax(TM) appears to work in part by
enhancing levels of Foxp3+ Tregs, which may help regulate expression of
pathogenic T cells in MS patients. The three TCR peptides combined in
NeuroVax(TM) correspond to one or more TCR gene families which are over
expressed in 90% of MS patients. Previous clinical trials conducted by the
Company and other independent researchers have associated diminished levels
of Foxp3+ Treg responses with the pathogenesis and progression of MS. This
same mechanism appears to be important in the pathogenesis of other
autoimmune diseases such as RA and psoriasis.
About the Study
These new mechanistic clinical data are from a recently completed open-
label study examining immunological and clinical parameters in 27
NeuroVax(TM) treatment-naïve and nine previously NeuroVax(TM) vaccinated
subjects with various forms of MS. Study participants received monthly
injections of NeuroVax(TM) over a one year period.
About OHSU
Oregon Health & Science University, located in Portland, OR., includes
the schools of dentistry, medicine, nursing and science and engineering;
OHSU Hospital and Doernbecher Children's Hospital; numerous primary care
and specialty clinics; multiple research institutes; and several outreach
and community service units.
About Orchestra Therapeutics
Orchestra Therapeutics, Inc., formerly The Immune Response Corporation
(OTCBB: OCHT, formerly IMRP), is an immuno-pharmaceutical company focused
on the discovery and development of novel treatments for autoimmune
diseases. The Company's lead immune-based therapeutic product candidate is
NeuroVax(TM) for the treatment of MS. In addition to MS, the Company has
proprietary technology and prior clinical experience for evaluation of TCR
peptide-based immune therapies for RA and psoriasis.
The Company also has two HIV product candidates, Remune(R) and IR103.
The 52-week data from the first large cohort of HIV clinical trial
participants from a now-terminated Phase II clinical trial have already
been gathered, and analysis of the data will be completed and disclosed in
the second quarter of 2007. Based on this data, the Company will consider
strategic alternatives for the HIV program.
The targeted strategy behind the Company's immune-based therapies is
reflected in the name Orchestra. Rather than disrupting the function of the
entire immune system, these therapeutic vaccines are designed to elicit a
very specific response -- akin to correcting one instrument in an orchestra
that is out of tune -- to help control disease.
This news release contains forward-looking statements. Forward-looking
statements are often signaled by forms of words such as should, could,
will, might, plan, projection, forecast, expect, guidance, potential and
developing. Actual results could vary materially from those expected due to
a variety of risk factors, including whether the Company will continue as a
going concern and successfully raise proceeds from financing activities
sufficient to fund operations and clinical trials of NeuroVax(TM),
Remune(R) or IR103, the uncertainty of successful completion of any such
clinical trials, the fact that the Company has not succeeded in
commercializing any drug, the risk that NeuroVax(TM), Remune(R) or IR103
might not prove to be effective as a therapeutic vaccine, whether future
trials will be conducted and whether the results of such trials will
coincide with the results of NeuroVax(TM), Remune(R) or IR103 in
preclinical trials and/or earlier clinical trials and the unresolved status
of the Company's HIV program. A more extensive set of risks is set forth in
Orchestra Therapeutics' SEC filings including, but not limited to, its
Annual Report on Form 10-K for the year ended December 31, 2006, and its
subsequent Quarterly Report filed on Form 10-Q. The Company undertakes no
obligation to update the results of these forward-looking statements to
reflect events or circumstances after today or to reflect the occurrence of
unanticipated events.
NeuroVax(TM) is a trademark of Orchestra Therapeutics, Inc. Remune(R)
is a registered trademark of Orchestra Therapeutics, Inc.
MEDIA CONTACT:
Rachel Kessler
Chamberlain Communications Group
(212) 389-9155
rkessler@chamberlainpr.com
INVESTOR CONTACT:
Robert Giordano
ROI Associates
(212) 495-0201
rgiordano@roiny.com
COMPANY CONTACT:
Michael K. Green, COO
Orchestra Therapeutics, Inc.
(760) 431-7080
info@orchestratherapeutics
SOURCE Orchestra Therapeutics, Inc.
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Related links:
http://www.orchestratherapeutics.com
CONTACT:
MEDIA, Rachel Kessler of Chamberlain
Communications Group, +1-212-389-9155,
rkessler@chamberlainpr.com, for Orchestra Therapeutics, Inc.;
INVESTORS, Robert Giordano of ROI Associates, +1-212-495-0201,
rgiordano@roiny.com, for Orchestra Therapeutics, Inc.; COMPANY,
Michael K. Green, COO of Orchestra Therapeutics, Inc.,
+1-760-431-7080, info@orchestratherapeutics
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